Study Objective: To evaluate the components of commonly used central venous catheter kits with respect to the potential for guidewire-mediated complications during catheter placement.Design: Prospective, nonrandomized, observational study.Setting: Six academic hospitals across the United States.Patients: NoneInterventions: None.Measurements and Main Results: 30 commercially manufactured catheter kits (15 tunneled, 15 nontunneled) were opened and evaluated. The catheter or sheath to be introduced was measured and a corresponding ideal guidewire Length was calculated. The ideal Length was then compared to the actual Length, and differences were tabulated. Wire tip configuration and the presence and pattern of distance markings were recorded and, in conjunction with the catheter and wire Length discrepancies, were used to grade the relative risk of introducing excess guidewire during catheter placement. Of 30 kits evaluated, 14 (46.7%) had guidewires more than 20 cm longer than necessary. The mean excess wire length was 15 cm (range: 8 to 55 cm) and did not differ significantly between tunneled and nontunneled catheter kits. Only 10 kits (33.3%) had distance markings of any type, and there was no standardization among them; none corresponded to previously published recommendations. There was potential risk of excess wire introduction in 18 catheter kits, of which seven were nontunneled devices designed for bedside placement.Conclusions: The design of commonly employed central venous access catheter kits is such that there is a mismatch between guidewire and catheter length and a general lack of guidewire markings. We believe that these designs may predispose to the introduction of excess guidewire and result in guidewire-mediated complications during catheter placement. This risk can likely be reduced by matching the guidewires to the devices placed over them and by standardizing guidewire distance markings. (C) 2003 by Elsevier Inc.
We have read with interest numerous articles in the Journal of Vascular Surgery since Liau et al1Liau C Ho F Chen M Lee Y. Treatment of iatrogenic femoral artery pseudoaneurysm with percutaneous thrombin injection.J Vasc Surg. 1997; 26: 18-23Abstract Full Text Full Text PDF PubMed Scopus (196) Google Scholar first reported the use of bovine thrombin injection for treatment of femoral artery pseudoaneurysms. Subsequent authors have advocated percutaneous ultrasound-guided thrombin injection as the preferred treatment for this condition, typically citing improved speed, effectiveness, and patient tolerance versus ultrasound-guided compression. We have performed thrombin injection with success rates similar to those in the literature, but we have done so with caution and only after careful patient selection. While recognizing the potential for mechanical complications with thrombin injection (eg, thromboembolism), most authors forget or ignore other issues inherent to the material itself. Bovine thrombin is approved by the Food and Drug Administration for topical application, but its intravascular use is off-label. Biologic compounds such as bovine thrombin are assayed for activity and sterility, not purity, and bovine thrombin contains other bovine plasma proteins such as factor V. Bovine thrombin is highly immunogenic, and numerous reports document immune-mediated reactions to its topical use, including fatal hemorrhagic complications.2Dorion RP Hamati HF Landis B Frey C Heydt D Carey D. Risk and clinical significance of developing antibodies induced by topical thrombin preparations.Arch Pathol Lab Med. 1998; 122: 887-894PubMed Google Scholar, 3Ortel TL Mercer MC Thames EH Moore KD Lawson JH. Immunologic impact and clinical outcomes after surgical exposure to bovine thrombin.Ann Surg. 2001; 233: 88-96Crossref PubMed Scopus (197) Google Scholar Dorion et al2Dorion RP Hamati HF Landis B Frey C Heydt D Carey D. Risk and clinical significance of developing antibodies induced by topical thrombin preparations.Arch Pathol Lab Med. 1998; 122: 887-894PubMed Google Scholar reviewed blood samples from 120 patients exposed to topical bovine thrombin and found that 12 patients (10%) demonstrated antibodies to bovine thrombin and other coagulation factors. In 2 patients (1.7%) severe bleeding developed, requiring complex management. Repeated exposure to bovine thrombin was associated with an eightfold increase in incidence of antibody formation: 7 of 18 patients (39%) versus 5 of 102 patients (5%) (P <.001). In a prospective study of 150 cardiac surgery patients exposed to topical bovine thrombin, Ortel et al3Ortel TL Mercer MC Thames EH Moore KD Lawson JH. Immunologic impact and clinical outcomes after surgical exposure to bovine thrombin.Ann Surg. 2001; 233: 88-96Crossref PubMed Scopus (197) Google Scholar reported that 51% had elevated antibodies to human coagulation proteins, most commonly factor V. Coagulopathy was common in these patients, but clinically significant adverse events occurred more frequently in patients who, because of previous exposure, had elevated concentrations of multiple antibodies before surgery. The unadjusted odds ratio of an adverse event in this setting was calculated at 5.40. Intravascular use likely has similar potential for sensitization, although this has not yet been reported in the literature. Of interest, two published reports describe “allergic”-type reactions after use of bovine thrombin for arterial pseudoaneurysm treatment, including anaphylaxis in one patient4Pope M Johnston KW. Anaphylaxis after thrombin injection of a femoral artery pseudoaneurysm: Recommendations for prevention.J Vasc Surg. 2000; 32: 190-191Abstract Full Text Full Text PDF PubMed Scopus (132) Google Scholar and generalized urticarial reaction in another patient.5Sheldon PJ Oglevie SB Kaplan LA. Prolonged generalized urticarial reaction after percutaneous thrombin injection for treatment of a femoral artery pseudoaneurysm.J Vasc Interv Radiol. 2000; 11: 759-761Abstract Full Text Full Text PDF PubMed Scopus (50) Google Scholar Considering these reports, it seems prudent to limit the use of intravascular bovine thrombin to those cases that truly warrant it. An alternative, human thrombin, may be less immunogenic and is commercially available as a fibrin sealant. Two published reports describe use of human thrombin to treat arterial pseudoaneurysms, with results similar to those with bovine thrombin.6Paulson EK Nelson RC Mayes CE Sheafor DH Sketch MH Kliewer MA. Sonographically guided thrombin injection of iatrogenic femoral pseudoaneurysms: further experience of a single institution.Am J Radiol. 2001; 177: 309-316Google Scholar, 7Elford J Burrell C Freeman S Roobottom C. Human thrombin injection for percutaneous treatment of iatrogenic pseudoaneurysms.Cardiovasc Intervent Radiol. 2002; 25: 115-118Crossref PubMed Scopus (44) Google Scholar We currently maintain bovine thrombin in our armamentarium, but recognize its potential for causing serious injury to our patients, especially those who have had prior exposure to bovine thrombin, topical or otherwise. We reserve the use of bovine thrombin for those patients in whom graded compression has failed or is not amenable. In our opinion, any history of bovine thrombin exposure is a contraindication to its further use. Absent other options, most patients can tolerate limited surgical femoral exposure with direct repair.
PURPOSE:To evaluate the effects of catheter-directed thrombin in the peripheral arterial circulation of swine.MATERIALS AND METHODS:Thrombin was injected into a single femoral artery in 20 domestic swine. Each of five animals from four dose groups received 50, 150, 250, or 1,000 U as a single dose. Bilateral femoral arterial flow was monitored for as long as 4 hours and evaluated relative to baseline and contralateral limb flow. Interval arteriographic results were evaluated by segmental patency and a numeric angiographic score.RESULTS:Mean baseline flow was 136 mL/min +/- 44, with an internal arterial diameter of 3.4 mm +/- 0.5. A transient increase in blood flow after thrombin administration was followed by diminished flow and thrombosis. These findings varied directly with dose and inversely with baseline flow. Angiographic and flow abnormalities generally improved with time and recovery was generally better in swine that received 50 or 1,000 U than in other groups. However, one animal that received 1,000 U (13.2 U/mL/min) developed stable, complete limb thrombosis. The degree of recovery varied with thrombin dose and thrombus location. At doses greater than 50 U (0.33 U/mL/min +/- 0.05), abnormalities were commonly persistent. Animals receiving the 150-U dose (1.33 U/mL/min +/- 0.41) had a higher incidence of persistent distal occlusion. Distal occlusions were less likely to resolve than proximal occlusions.CONCLUSIONS:The effect of intraarterial thrombin is directly related to dose and inversely related to baseline blood flow. In swine, a threshold for significant flow disruption and thrombosis exists above a dose of 50 U (0.33 U/mL/min +/- 0.05). A threshold dose for irreversible occlusion may also exist. Although small amounts of thrombin in a high-flow vessel may not cause significant complication, administration into the arterial circulation should be avoided.
UTERINE artery embolization (UAE) (also known as uterine fibroid embolization) as a definitive treatment for symptomatic uterine leiomyomata was first reported in 1995 ( 1 Ravina JH Herbreteau D Ciraru-Vigneron N et al. Arterial embolisation to treat uterine myomata. Lancet. 1995; 346: 671-672 Abstract PubMed Google Scholar ). While this and subsequent reports have shown great promise for the technique, clinical failure has been seen in as many as 20% of patients ( 2 Ravina JH Bouret JM Ciraru-Vigneron N et al. Recourse to particular arterial embolization in the treatment of some uterine leiomyoma. Bull Acad Natl Med. 1997; 181: 233-243 PubMed Google Scholar , 3 Goodwin SC Vedantham S McLucas B et al. Preliminary experience with uterine artery embolization for uterine fibroids. JVIR. 1997; 8: 517-526 Abstract Full Text PDF Scopus (326) Google Scholar , 4 Worthington-Kirsch RL Popky GL Hutchins Jr, FL Uterine arterial embolization for the management of leiomyomas: quality-of-life assessment and clinical response. Radiology. 1998; 208: 625-629 PubMed Google Scholar , 5 Spies JB Scialli AR Jha RC et al. Initial results from uterine fibroid embolization for symptomatic leiomyomata. JVIR. 1999; 10: 1149-1157 Abstract Full Text PDF Scopus (259) Google Scholar , 6 Goodwin SC McLucas B Lee M et al. Uterine artery embolization for the treatment of uterine leiomyomata midterm results. JVIR. 1999; 10: 1159-1165 Abstract Full Text PDF Scopus (407) Google Scholar , 7 Hutchins Jr, FL Worthington-Kirsch R Berkowitz RP Selective uterine artery embolization as primary treatment for symptomatic leiomyomata uteri. J Am Assoc Gynecol Laparosc. 1999; 6: 279-284 Abstract Full Text PDF PubMed Scopus (237) Google Scholar ). Among that group have been women undergoing unilateral embolization or having arterial supply to their fibroids from sources other than the uterine artery ( 3 Goodwin SC Vedantham S McLucas B et al. Preliminary experience with uterine artery embolization for uterine fibroids. JVIR. 1997; 8: 517-526 Abstract Full Text PDF Scopus (326) Google Scholar , 7 Hutchins Jr, FL Worthington-Kirsch R Berkowitz RP Selective uterine artery embolization as primary treatment for symptomatic leiomyomata uteri. J Am Assoc Gynecol Laparosc. 1999; 6: 279-284 Abstract Full Text PDF PubMed Scopus (237) Google Scholar , 8 Nikolic B Spies JB Abbara S Goodwin S Ovarian artery supply of uterine fibroids as a cause of treatment failure after uterine artery embolization: a case report. JVIR. 1999; 10: 1167-1170 Abstract Full Text PDF Scopus (103) Google Scholar ). This report describes a patient in whom the right ovarian artery provided the dominant arterial supply to a uterine fibroid. These collateral branches were selectively embolized via the ovarian artery with use of a microcatheter technique, giving satisfactory clinical and anatomic results.